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Greenlight Guru Medical Device Blog

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How the MDSAP Grading System Works - Featured Image

How the MDSAP Grading System Works

The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...
Greenlight Guru Announces Medical Device HQ Partnership - Featured Image

Greenlight Guru Announces Medical Device HQ Partnership

New partnership with training experts will allow the medical device industry’s leading software plat...
Greenlight Guru Receives Strategic Growth Investment from JMI Equity - Featured Image

Greenlight Guru Receives Strategic Growth Investment from JMI Equity

New investment will allow the medical device industry’s leading software platform to rapidly expand ...
How MHRA is Regulating Medical Devices in the UK after Brexit - Featured Image

How MHRA is Regulating Medical Devices in the UK after Brexit

If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in ...
Greenlight Guru Launches Global Medical Device Job Board - Featured Image

Greenlight Guru Launches Global Medical Device Job Board

Leading medical device QMS provider introduces industry-specific job board to provide companies excl...
How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation - Featured Image

How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation

Clinical investigations play an important role in your journey of bringing a medical device to marke...
FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Would things be simpler in the medical device regulatory space if there was global harmonization acr...
Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board - Featured Image

Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board

Leading medical device QMS provider establishes Regulatory Advisory Board comprised of global regula...
5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device - Featured Image

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea...
What is 21 CFR 812 - Investigational Device Exemption? - Featured Image

What is 21 CFR 812 - Investigational Device Exemption?

Could your medical device qualify for an investigational device exemption (IDE)?
How to Make Your QMS Comply with EU MDR and IVDR - Featured Image

How to Make Your QMS Comply with EU MDR and IVDR

If your company has or is looking to place medical devices on the EU market, you need to know about ...
How SOLIUS Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks - Featured Image

How SOLIUS Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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